Micropulse Diode Laser Treatment for Chronic Central Serous Chorioretinopathy

This study has been completed.
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01327170
First received: March 29, 2011
Last updated: March 30, 2011
Last verified: March 2011
  Purpose

The aim of this study was to evaluate safety and therapeutic response to micropulse diode 810nm laser treatment in patients with chronic central serous chorioretinopathy.


Condition Intervention
Central Serous Chorioretinopathy
Procedure: Subthreshold diode micropulse laser

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Micropulse Diode Laser Treatment for Chronic Central Serous Chorioretinopathy: Evaluation by Fundus Autofluorescence and Spectral Domain Optical Coherence Tomography

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Best corrected visual acuity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Best corrected visual acuity measured by ETDRS chart at baseline, 1, 3, 6, 9 and 12 months


Secondary Outcome Measures:
  • Macular subretinal fluid [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Central macular thickness measured by spectral-domain optical coherence tomography at baseline, 1, 3, 6, 9 and 12 months

  • Leakage at fluorescein angiogram [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Leakage at fluorescein angiogram evaluated at baseline, 3, 6, 9 and 12 months


Enrollment: 15
Study Start Date: November 2008
Study Completion Date: June 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Subthreshold diode micropulse laser
Subthreshold diode micropulse laser in patients with chronic central serous chorioretinopathy
Procedure: Subthreshold diode micropulse laser
Sham Comparator: Sham
Sham group simulating the laser treatment
Procedure: Subthreshold diode micropulse laser

Detailed Description:

Most of the cases of central serous chorioretinopathy (CSC) recur spontaneously within three months of disease. After 3 months without resolution of acute CSC or in chronic CSC, continuous wave laser photocoagulation or photodynamic therapy should be considered. Direct threshold continuous photocoagulation treatment can shorten the duration of the serous detachment, but it is not appropriate for juxtafoveal or subfoveal leakage point.Subvisible photocoagulation potentially localizes and decreases chorioretinal thermic burn. Subthreshold diode micropulse (SDM) laser using a 810nm diode laser may spare the damage to the neural retina by raising the temperature of the RPE to just below the protein-denaturation threshold so that the thermal wave that reaches the neural retina is insufficient to cause neither damage nor clinically visible end-point. This therapeutic laser modality offers the possibility to minimize the iatrogenic retinal lesion.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic active central serous chorioretinopathy lasting more than 6 months
  • Leakage at fluorescein angiogram

Exclusion Criteria:

  • Opacities of the clear refractive media of the eye
  • Any intraocular surgery within the 6 months prior to study entry
  • Prior vitrectomy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01327170

Locations
Brazil
Federal University of São Paulo
São Paulo, Brazil, 04023-062
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Fernanda P Magalhaes, MD Federal University of São Paulo
  More Information

No publications provided

Responsible Party: Fernanda Pedreira Magalhães, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01327170     History of Changes
Other Study ID Numbers: SDMCCSC-FM
Study First Received: March 29, 2011
Last Updated: March 30, 2011
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Central Serous Chorioretinopathy
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 16, 2014